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临床试验/NCT03498092
NCT03498092已完成不适用

Comparative Study of Bupivacaine Versus Bupivacaine-Dexmedetomidine in Ultrasound Guided Serratus Plane Block for Patients Undergoing Modified Radical Mastectomy

Alaa Mazy1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年8月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
The time of the first analgesia request

研究概览

简要总结

The serratus plane block (SPB) described by Blanco et al, 2013 is a progression from the work with the Pecs I and II blocks. The serratus muscle is a superficial and easily identified muscle and considered a true landmark to perform thoracic wall blocks because lateral cutaneous branches of the intercostal nerves pierce it in the mid-axillary line. A local anesthetic (LA) is injected under ultrasound (US) guidance either superficial or deep to serratus anterior muscle providing predictable and relatively long-lasting regional anesthesia, which would be suitable for surgical procedures performed on the chest wall.

The linear US probe of frequency (6-13 MHz) is placed over the mid-clavicular region in a sagittal plane.The ribs are counted inferiorly and laterally until the fifth rib in the midaxillary line is identified.The latissimus dorsi, teres major, and serratus muscles are identified.

详细描述

Possible regional techniques for breast surgery include selective intercostal nerve blockade, thoracic paravertebral blockade, thoracic epidural, intrapleural, local wound infiltration. Each of these techniques has advantages and disadvantages. In general, local or wound infiltration is safe but limited in terms of duration of action, depending on the local anesthetic (LA) used. More invasive techniques such as selective intercostal nerve blocks and thoracic paravertebral blockade may be complicated by pneumothorax or transient Horner's syndrome These techniques are also may be associated with higher risk of local anesthetic toxicity. Besides the neurological side-effects associated with thoracic epidural and paravertebral blocks such as post-sympathectomy hypotension and bradycardia, total spinal block, paraplegia, epidural hematoma, unpredictable spread, intravascular injection also requires special skill precluding their routine use in the setting of day-case surgery. With the use of ultrasound (US) devices in anesthetic practice, newer regional techniques based on detailed knowledge of innervations of the breast are developed as the pectoral nerve (Pecs) block I and II.The breast innervations briefly include lateral and medial pectoral nerves that arise from the brachial plexus innervating the pectoral muscles.The anterior divisions of the thoracic intercostal nerves from T2 to T6. They give off lateral and anterior branches. The Lateral branches pierce the external intercostalis and the serratus anterior muscles at the mid-axillary line to give off anterior and posterior terminal cutaneous branches. The lateral cutaneous branch of the second intercostal nerve does not divide and it is called the intercostobrachial nerve.The Anterior branches pierce the internal intercostalis muscle, the intercostal membranes, and pectoralis major to supply the breast in its medial aspect.The long thoracic nerve passes on the serratus anterior muscle supplying it. The thoracodorsal nerve innervates the latissimus dorsi muscle.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients of American Society of Anesthesiologists (ASA) grade I - III.
  • Scheduled for unilateral modified radical mastectomy.

排除标准

  • Patient with the skin infection in the axilla.
  • Allergy to local anesthetics of the amide type.
  • Patient refusal.

研究组 & 干预措施

Bupivacaine-Dexmedetomidine group

Experimental

After general anesthesia, patients will receive a cocktail of isobaric bupivacaine 2.5 mg/ml plus 5 micrograms (mcg)/ml adrenaline and 1mcg/kg dexmedetomidine in a volume of 0.5 ml/kg injected superficial to serratus muscle between and below latissimus dorsi muscle.

干预措施: Bupivacaine-Dexmedetomidine (Drug)

Bupivacaine group

Active Comparator

After general anesthesia, patients will receive a cocktail of isobaric bupivacaine 2.5 mg/ml plus 5 micrograms (mcg)/ml adrenaline in a volume of 0.5 ml/kg injected superficial to serratus muscle between and below latissimus dorsi muscle.

干预措施: Bupivacaine (Drug)

Saline group

Placebo Comparator

This group will serve as a control and blinding group and will receive saline infiltration in the same manner.

干预措施: General anesthesia (Drug)

结局指标

主要结局

The time of the first analgesia request

时间窗: 24 hours postoperative

minutes

次要结局

  • The total analgesic requirements (Ketorolac)(24 hours postoperative)
  • Amount of fentanyl consumption(Intraoperative.)
  • Mean arterial blood pressure(intraoperative every 30 minutes, and postoperative at 2, 4, 6, 10, 16, 24 hours)
  • Sedation assessed by the observer's assessment of alertness & sedation score(postoperative:10, 20, 30 minutes after extubation)
  • The Incidence of postoperative nausea and vomiting(postoperative for 24 hours)
  • Pain assessed by Visual Analogue Scale(Postoperative: immediately after surgery, 2, 4, 6,10, 16, 24 hours postoperative)
  • Heat rate(intraoperative every 30 minutes, and postoperative at 2, 4, 6, 10, 16, 24 hours)
  • Patient satisfaction assessed by a visual analogue score(postoperative 24 hours after surgery)

研究者

发起方
Alaa Mazy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alaa Mazy

associate professor of anesthesia and surgical intensive care

Mansoura University

研究点 (1)

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